1. Field of the Invention
This invention relates to a crystalline form of 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate useful as an inhibitor of sodium-dependent glucose transporter, to methods for its preparation and isolation, to pharmaceutical compositions which include the compound and a pharmaceutically acceptable carrier, and to pharmaceutical methods of treatment.
2. Description of the Related Art
WO 2005/012326 pamphlet discloses a class of compounds that are inhibitors of sodium-dependent glucose transporter (SGLT) and thus of therapeutic use for treatment of diabetes, obesity, diabetic complications, and the like. There is described in WO 2005/012326 pamphlet 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene of formula (I):

In general, for commercial use it is important that a product should have good handling qualities. Additionally, there is a need to produce the product in a pure and crystalline form to enable formulations to meet exacting pharmaceutical requirements and specifications.
And it is desirable that the product should be in a form that is readily filterable and easily dried.
Additionally, it is economically desirable that the product be stable for extended periods of time without the need for specialized storage conditions.
But there have been difficulties in obtaining a crystal form of the compound of formula (I) from organic solvents.
It has now been discovered that the compound of formula (I) hemihydrate can be produced in a crystalline form in a manner reproducible on a commercial scale.